Technology has spreads its wings in every corner of this world. The advanced elements of technology today, do not refrain from a computer to do only one task or be useful to a specific sector/industry. This is where the Computer system validation comes into play. It allows a computer or a system to behave in a specific way and meet requirements as well as do what it is exactly designed to do.
Also called ‘computerized system validation’, CSV is a documented process of assuring that a computer system performs tasks and functions the same way it is designed to do. The biggest application of CSV is its growing popularity in the Pharma as well as food industries. The validation process begins with the system proposal/requirements definition; continues until system retirement and retention of the e-records based on regulatory rules.
As the main application of the computerized system validation revolves around Pharma and Food industries, it has grown immensely popular with time. Computer system validation has become a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality.
It is essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. (Courtesy- qedge.sarjen)
CSV has been offering a wide range of services that range from regulated businesses, pharmaceutical, biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories.
There are several benefits of using computerized system validation. Some of them are:
- It has the ability to provide all required documents readily by the FDA, other regulatory agencies to your customers.
- CSV helps in maximizing the value of the computer system.
- Computerized system validation will help in reducing labor costs by enhancing employee efficiency.
- The computerized system validation also helps in effective project management that is scheduled on time and a specific budget.
- It will save you loads of money and time as it can detect defects at an early stage.
- Apart from this, CSV will help in reducing the risk of legal liability, and not regulatory makes it one of the most important reasons to perform validation.
In simple words, Computer system validation (often called as computerized validation or CSV) is the simple process of documenting that a computer system meets a set of defined system requirements as well as other specific needs.